Exelixis, Inc. (NASDAQ:EXEL) today reported promising interim data from an ongoing phase 2 trial of XL184 in patients with recurrent glioblastoma (GB), the most common and aggressive form of brain cancer. Dr. Patrick Wen from the Dana Farber Cancer Institute in Boston, MA will present the data in an Oral Session (Abstract #2006) on Saturday, June 5 at 5:00 p.m. at the 2010 Annual Meeting of the American Society of Clinical Oncology in Chicago.
“We are encouraged by the clinical activity, tolerability and safety profile of XL184 at the 125 mg dose in recurrent GB”
The phase 2 study is evaluating the safety, tolerability, and clinical activity of XL184 at continuous daily doses of 175 mg or 125 mg in patients with previously treated GB, and includes two prospectively defined populations of patients who either did or did not receive prior therapy with an antiangiogenic agent. As of May 19, 2010 a total of 195 patients in first or second relapse have been enrolled in three successive cohorts. Efficacy (consisting of response assessment and progression-free survival) and safety data are available for 105 and 153 patients, respectively, with a data cut-off date of April 28, 2010.
As previously reported, 46 patients were treated at the 175 mg dose in a fully enrolled cohort 1. Newly reported data includes 59 patients treated at the lower dose of 125 mg in a fully enrolled cohort 2. Cohort 3 (125 mg), which uses the newly endorsed response assessment in neuro-oncology (RANO) response criteria, continues to enroll with the majority of patients not yet evaluable for response. Substantial activity of XL184 was observed, with 82% of the overall trial population and 91% of the antiangiogenic therapy naïve population with at least one post-baseline MRI scan experiencing tumor reduction as determined by an independent radiology facility (IRF) using a blinded double-reader paradigm.
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